US Pharm
. 2006;6:102-105.
FDA regulations require that
"labeling on or within the package from which the drug is to be dispensed
bears adequate information for its use" [(21 CFR § 201.100(c)(1)]. This
regulation's intent is to ensure that full prescribing information is
available to the pharmacist who dispenses any prescription drug product. As it
is physically attached to or contained within the drug packaging, this
information is called a medication package insert (PI).
In August 1999, the PhRMA
Paperless Labeling Task Force proposed replacing the paper PI with a paperless
or electronic version. In its recommendation, the Task Force noted a number of
problems with current paper-based approaches in providing pharmacists with
full prescribing information.
One problem with paper PIs is
accuracy, particularly for drugs with frequent labeling changes. Each year,
the FDA requires labeling changes for hundreds of drugs as information is
added or altered (i.e., changes to indications, warnings, side effects, dosing
recommendations). Thus, when the pharmacist accesses prescribing information
using the paper PI or via a standard reference text, he or she may be relying
on outdated or incomplete information. Moreover, short of contacting the
product's manufacturer, the pharmacist has no way to determine whether the
information is current.
PDR On-Demand
One paperless
labeling option is Thomson Healthcare's PDR On-Demand. This
device consists of a bar code–enabled touch screen monitor about the size and
shape of an 8" X 10" picture frame. The stand-alone device is updated
daily with current product information via automated dial-in to a database
administered by Thomson Healthcare. To retrieve a drug's labeling information,
a pharmacist scans the package's bar code or searches the database using the
drug's National Drug Code or name on the device's screen.
Beginning September 2004,
Thomson Healthcare began a nationwide field trial of PDR On-Demand by
placing the device in 88 pharmacies that were selected and randomized by an
independent consultant recruited by PhRMA. Although the device was fully
functional, it contained labeling information for only 800 prescription drug
products. The device was attached to a dedicated printer that allowed the
pharmacist to print complete labeling information for a product. In compliance
with FDA requirements, pharmacists could print only all or none of the PI, not
selected parts. The study assessed pharmacists' attitudes toward--and
satisfaction with--PDR On-Demand as an electronic alternative to
printed PIs.
Methods
Data were collected via
survey from a designated contact pharmacist practicing in each of the 88
pharmacies participating in the field trial. There were 61 chain pharmacies,
26 independent pharmacies, and one government-owned family health center. The
pharmacies operated in 24 states and Puerto Rico. Data collection began in
December 2004 via surveys faxed to designated contacts at each pharmacy.
Results
Seventy-five
pharmacists completed the surveys, for a response rate of 85.2%. Although
pharmacists who practiced in chain pharmacy organizations accounted for the
majority of respondents, those practicing in clinic, government, and
traditional independent community pharmacies had significantly higher response
rates in proportion to the chain pharmacists. Because the clinic and
government pharmacies closely paralleled the practice settings of independent
community pharmacies, they were classified as independently owned pharmacies
for all subsequent analyses.
Current Use of Paper PIs:
In response to questions regarding how pharmacists use printed PIs, 66
respondents (88%) stated that they discard them. Another six (8%) indicated
that they typically give the PI to a patient, and three (4%) stated that they
routinely give the PI to other health care professionals.
When respondents were asked
how often they refer to the paper PI for drug information, they most
frequently stated "once or twice a week" (49.3%), followed by "once or twice a
month" (29.3%). Nine respondents (12%) indicated that they refer to the paper
PI at least daily, and seven (9.3%) indicated that they almost never refer to
it.
When asked why they refer to
the paper PI, pharmacists most frequently cited checking the side effects of a
drug, followed by checking dosing information, learning about a new product,
checking drug interactions, and checking how a drug product is supplied. Chain
pharmacists referred to the PI more often than did independent pharmacists for
all types of information except checking side effects. However, these
differences were not statistically significant (P >.05). As one might
expect, frequent PI users referred to the PI more often for all types of
information than did infrequent users, although the differences between the
two groups were not statistically significant. Respondents also stated that
they referred to the PI to check ingredients, including inactive ingredients;
review the mechanism of action; check contraindications; and find guidance on
splitting tablets.
Comparing Paper PIs to
PDR On-Demand: Survey
respondents compared the PDR On-Demand device to the paper PI on six
usability characteristics. Pharmacists perceived the electronic version to be
superior to the paper PI for every characteristic except space requirements
for the device and its dedicated printer. Respondents gave particularly high
scores for the legibility (i.e., font size, clarity) and ease of use of the
electronic device as compared to the paper PI. Although independent
pharmacists were more positive than were chain pharmacists, the differences
were not statistically significant. Similarly, frequent PI users were more
positive than were infrequent users regarding the comparative advantages of
the electronic version, but not significantly so.
Regarding whether respondents
would be more likely to refer to the PDR On-Demand device than to the
printed PI if all FDA-approved drugs were available in the device's database,
respondents indicated that they would be moderately more likely to do so. The
difference that practice setting made in responses to this question closely
approached statistical significance (P = .09), as independent
pharmacists scored this question higher than did chain pharmacists. The
difference between frequent and infrequent PI users was statistically
significant (P = .02), indicating that frequent users of PI information
would be more likely than infrequent users to use the electronic device if all
drugs were included in the database.
Discussion
Over half (61.3%)
of pharmacists who participated in the PDR On-Demand field trial and
survey indicated that they refer to PI information at least once a week, and
12% do so on a daily basis. Thus, while the paper PI is discarded most of the
time (88%), it continues to be an important and frequently consulted resource
for many community pharmacists.
Pharmacists surveyed viewed
the PDR On-Demand device as an acceptable--and, in most cases,
superior--alternative to paper PIs. Indeed, from October 15, 2004, to February
18, 2005, the average weekly number of labeling inquiries per pharmacy more
than doubled--increasing from 45 to 91. This represents a usage increase of
about 6% per week during the trial. While the legibility of the information
was a particularly important advantage, respondents also viewed the device as
superior in speed, accuracy/currency of information, ease of use, and
convenience. Moreover, these perceived advantages held across practice setting
and frequency of PI use.
The PDR On-Demand
compared least favorably with paper PIs in the amount of storage space
required. Although the device's footprint is no greater than that required for
an 8" ¥ 10" picture frame, it is connected to a dedicated printer
(16" wide ¥ 13" deep ¥7" high). Since countertop real
estate in the dispensing area of most community pharmacies is a scarce and
jealously guarded commodity, the annexation of any territory typically faces
opposition by pharmacy staff unless a compelling benefit can be shown.
Although it is unlikely the device could be made substantially smaller while
retaining some of the features that respondents preferred (e.g., legibility),
alternatives could be considered for the dedicated printer or for placement of
the unit. For instance, the unit could be wall mounted, and the printer could
be stored adjacent to or under the dispensing counter.
Nine respondents complained
about their inability to print selected pages or screens of information, as
the PDR On-Demand product has only an "all or none" option. Although
this option meets FDA requirements, it negates--at least in part--the otherwise
"environmentally friendly" nature of the paperless device that was noted by
one respondent.
Several respondents noted the
need for faster and easier screen navigation and the ability to more easily
find a specific topic on the PI, such as information on drug interactions. As
this information is contained in a pull-down menu, these comments suggest the
need for a more thorough orientation for future users.
While users clearly recognized
and valued the superior legibility of information on the device's screen
compared to that on the printed PI, two respondents recommended better
readability. Although users may increase the screen font size at any time, a
larger font size could be used as the default setting and/or users could set
their own default font size.
Two respondents suggested
adding drug identification, including photos of drugs, and another suggested
highlighting information that has changed in an updated PI to allow quick
review.
The results of this study
suggest that PDR On-Demand is an effective alternative to the paper PI
for providing pharmacists with access to full prescribing information on
prescription drugs. This product was preferred to paper PIs by pharmacists in
every usability characteristic that was studied except for its space
requirements. Assuming a future database that includes all marketed
prescription drugs, PDR On-Demand is more likely than the printed PI to
be used as a resource by community pharmacists.
--Jessica Jannicelli and Abigail
Brugger, section editors
To comment on this article, contact editor@uspharmacist.com